amisulpride / Generic mfg. - LARVOL DELTA

AMISULPRIDE FOR THE TREATMENT OF IDIOPATHIC GASTROPARESIS: RESULTS OF A DOUBLE-BLINDED PLACEBO-CONTROLLED STUDY (DDW 2025) - No abstract available

Clinical • Gastrointestinal Disorder

Antipsychotics cause reversible structural brain changes within one week. (PubMed, Neuropsychopharmacology) - "Within arms, participants were randomized to receive daily doses of either the active compound (Arm 1= amisulpride 400 mg/day, N = 24; Arm 2= aripiprazole 10 mg/day, N = 24) for one week, followed by placebo or vice versa. Short-term exposure to either one of two different antipsychotics results in a transient increase in striatal volume measured with T1-weighted MRI that normalizes rapidly on stopping treatment without cortical changes. Our findings suggest that striatal volumetric MRI differences detected in people with schizophrenia taking antipsychotics are, at least in part, attributable to pharmacological effects."

Clinical • Journal • CNS Disorders • Psychiatry • Schizophrenia

Bioequivalence and Safety of Two Amisulpride Formulations in Healthy Chinese Subjects Under Fasting and Fed Conditions: A Randomized, Open‑Label, Single‑Dose, Crossover Study. (PubMed, Drugs R D) - "The test and reference amisulpride formulations were bioequivalent under fasting and fed conditions. Both formulations showed similar safety and tolerability in the population studied."

Journal • CNS Disorders

Efficacy of Adding Oral Amisulpride to Dual Prophylaxis for Postoperative Nausea and Vomiting in Patients at High Risk for Nausea and Vomiting Undergoing Gynecological Surgery (clinicaltrials.gov) - P2 | N=276 | Recruiting | Sponsor: Instituto do Cancer do Estado de São Paulo | Not yet recruiting ➔ Recruiting

Enrollment open • Gynecology

Aripiprazole alleviates the high prolactin levels induced by amisulpride via distinct molecular mechanisms: a network pharmacology and molecular docking study. (PubMed, BMC Psychiatry) - "These findings highlight the distinct signaling pathways and molecular networks involved in prolactin regulation by aripiprazole and amisulpride and provide new insights into the mechanisms of these drugs in schizophrenia treatment. Further pharmacological and clinical research is needed to validate the complex regulatory networks and in vivo effects."

Journal • CNS Disorders • Psychiatry • Schizophrenia • CDC42 • DRD2 • ER • MAPK3 • MMP9 • PPARG

Photodegradation of psychotropic medications: Impact on efficacy, safety, and drug properties. (PubMed, Comput Biol Med) - "Our results indicate that photoproducts such as amisulpride_TP166, TP246, quetiapine_D4, and quetiapine_PH1 show enhanced biological affinity and ADME-Tox profiles similar to their parent compounds, suggesting possible therapeutic advantages in their interaction with targeted receptors. However, some of the photocompounds exhibit lower predicted binding affinities when interacting with those receptors compared to their parent compounds, indicating a possible loss of function. These findings emphasize the need for further investigation into the effects and safety of drug photoproducts, particularly in the context of long-term pharmacotherapy."

Journal • Bipolar Disorder • CNS Disorders • Depression • Mood Disorders • Psychiatry • Schizophrenia

Sequential Multiple-Assignment Randomized Trials to Compare Antipsychotic Treatments(SMART-CAT) (clinicaltrials.gov) - P3 | N=762 | Completed | Sponsor: Shanghai Mental Health Center | Unknown status ➔ Completed | Phase classification: P4 ➔ P3 | N=1260 ➔ 762

Enrollment change • Phase classification • Trial completion • CNS Disorders • Psychiatry • Schizophrenia

Drug-associated hyperprolactinemia: a comprehensive disproportionality analysis based on the FAERS database. (PubMed, Eur J Pharmacol) - "Sensitivity analysis indicated that most signals remained robust, with risperidone exhibiting the strongest signal for HPRL, followed by amisulpride, paliperidone, fluphenazine, and thioridazine. In conclusion, we identified and ranked drugs associated with HPRL, primarily psychotropic medications, and observed variations in signal strength and onset time across gender and age. These findings emphasize the importance of individualized HPRL screening based on specific medications, gender, and age."

Journal • CNS Disorders

Efficacy of Adding Oral Amisulpride to Dual Prophylaxis for Postoperative Nausea and Vomiting in Patients At High Risk for Nausea and Vomiting Undergoing Gynecological Surgery (clinicaltrials.gov) - P2 | N=276 | Not yet recruiting | Sponsor: Instituto do Cancer do Estado de São Paulo

New P2 trial • Gynecology

QT Interval, Antipsychotics and Correlates Among Patients with Schizophrenia: Cross-Sectional Data from the Multicentric Real-World FACE-SZ. (PubMed, Drug Saf) - "The prescription of antipsychotics should always be accompanied by close monitoring of the QTc interval to prevent the risk of severe cardiac arrhythmia, particularly concerning clozapine."

Journal • Real-world evidence • Cardiovascular • CNS Disorders • Psychiatry • Schizophrenia

Paliperidone-induced neuroleptic malignant syndrome: A case report. (PubMed, Medicine (Baltimore)) - "Although NMS is not very common in patients using antipsychotics, it is important because it is an emergency condition that can result in death if not treated appropriately. Clinicians should consider NMS in patients taking atypical antipsychotics such as paliperidone."

Journal • Cardiovascular • CNS Disorders • Movement Disorders • Psychiatry • Schizophrenia

Aborted Sudden Cardiac Death Due to Acquired QT Prolongation: A Case Report. (PubMed, Cureus) - "We present the case of a 60-year-old woman with a history of schizoaffective disorder treated with escitalopram and amisulpride and a recent prescription for ciprofloxacin for a urinary tract infection, who was admitted following a cardiac arrest. This case highlights the importance of thorough medication review and early identification of individuals at risk for acquired LQTS to prevent potentially fatal arrhythmias. It also highlights the necessity of considering underlying genetic predisposition, especially in cases where QT prolongation persists despite the discontinuation of the offending agents and/or correction of other contributing factors, making genetic testing advisable in selected patients, as it will guide further management."

Journal • Cardiovascular • CNS Disorders • Endocrine Disorders • Heart Failure • Infectious Disease • Nephrology • Psychiatry • Schizophrenia

Comparative risk of QTc prolongation induced by second-generation antipsychotics in the real world: retrospective cohort study based on a hospital information system. (PubMed, BJPsych Open) - "Ziprasidone, amisulpride and olanzapine are associated with increased risk of QTc prolongation. Regular electrocardiogram monitoring is recommended when clinicians prescribe such drugs."

Journal • Real-world evidence • Retrospective data • Cardiovascular • CNS Disorders

Antipsychotic drug dosing and study discontinuation in schizophrenia: A systematic review and dose-response meta-analysis. (PubMed, Eur Neuropsychopharmacol) - "Dose discontinuation curves varied between the antipsychotics and included U-shaped, monotonic, and hyperbolic patterns. Future studies should consistently present disease-related and side-effect-related dropouts due to adverse events separately."

Journal • Retrospective data • Review • CNS Disorders • Psychiatry • Schizophrenia

Exploring the factors and outcomes of clozapine discontinuation in India: A retrospective analysis. (PubMed, Asian J Psychiatr) - "These results align with previous studies, showing that adverse effects and inadequate response are prominent reasons for clozapine discontinuation and demonstrate the possibility of clozapine retrial in selected patients. Managing adverse effects might result in improvement, at least to a mild degree. Clozapine discontinuation can be avoided in a cohort with non-serious adverse effects, given the superiority of clozapine in resistant schizophrenia."

Journal • Retrospective data • CNS Disorders • Psychiatry • Schizophrenia

Therapeutic effects of amisulpride in male schizophrenics: Role of short-chain fatty acids and gene expression changes. (PubMed, Physiol Behav) - "However, direct evidence linking these changes to gut-brain axis mechanisms remains insufficient. Further research is needed to elucidate the therapeutic implications of these metabolic and immunological alterations and their potential role in symptom modulation."

IO biomarker • Journal • CNS Disorders • Psychiatry • Schizophrenia • CD14 • HDAC1 • TLR2 • TLR4

A New Trick of Old Dogs: Can Kappa Opioid Receptor Antagonist Properties of Antidepressants Assist in Treating Treatment-Resistant Depression (TRD)? (PubMed, Pharmaceuticals (Basel)) - " The antidepressants mianserin and mirtazapine (separately) induced dose-dependent antinociception, each yielding a biphasic dose-response curve. Similarly, the antidepressant venlafaxine produced a potent effect and reboxetine produced a weak effect. The antipsychotics risperidone and amisulpride exhibited a dose-dependent antinociceptive effect... Clinical studies are mandatory to establish the potential efficacy of augmentation of the treatment with antidepressants with these drugs in persons with treatment-resistant depression and the optimal dosage of medications prescribed. We suggest a possible beneficial effect of antidepressants with kappa antagonistic properties."

Journal • Addiction (Opioid and Alcohol) • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Optimizing Intranasal Amisulpride Loaded Nanostructured Lipid Carriers: Formulation, Development, and Characterization Parameters. (PubMed, Pharm Nanotechnol) - "The right combination of the formulation compositions based on studying the effect of each factor on the main formulation characteristics can serve as the basis for a successful intranasal amisulpride-loaded nanostructured lipid carrier."

Journal

Developing an Ecotoxicological Classification for Frequently Used Drugs in Primary Care. (PubMed, Int J Environ Res Public Health) - "Fifteen APIs were designated as safe (category (1):paracetamol, tramadol, amisulpride, citalopram, mirtazapine, metformin, gabapentin, lamotrigine, primidone, candesartan, irbesartan, atenolol, hydrochlorothiazide, ofloxacin, sulfadiazine), eleven as intermediately safe, and nine were of concern (azithromycin, ciprofloxacin, clarithromycin, sulfamethoxazole, carbamazepine, diclofenac, ibuprofen, iomeprol, iopromide). Where data do exist, we observed significant differences in environmental impact among the same class of drugs. Our classification could therefore help guide doctors to adopt more eco-friendly prescriptions."

Journal

The Effect of Age on Antipsychotic Serum Concentration in Males and Females: A Study Based on Therapeutic Drug Monitoring Data From 19,926 Patients. (PubMed, Ther Drug Monit) - "The age-dependent increase in dose-adjusted serum concentrations among males and females varied across different antipsychotics and was highest for risperidone. These findings emphasize the importance of proper monitoring of antipsychotic use in older adults."

Journal • CNS Disorders

Sex differences in the peripheral levels of cytokines during 12-month antipsychotic treatment in a drug-naïve schizophrenia spectrum cohort. (PubMed, Brain Behav Immun Health) - "This study reports pre-planned secondary outcomes from the BeSt InTro Study - a pragmatic, semi-randomised, rater-blinded comparison of amisulpride, aripiprazole, and olanzapine. Our findings add to already established sex differences in schizophrenia pathophysiology and might have a potential role for future treatment guidelines. The Research Council of Norway, the Western Norway Regional Health Trust, and the participating hospitals and universities provided funding for this study."

Journal • CNS Disorders • Psychiatry • Schizophrenia • CRP • IFNG • IL10 • IL17A • IL1B • IL2 • IL4 • IL6 • TNFA

Potential risk analysis of antipsychotics-related constipation from the FDA Adverse Event Reporting System. (PubMed, Expert Opin Drug Saf) - "Except for aripiprazole and ziprasidone, the p values of the other drugs were all less than 0.05. The RORs values in descending order:amisulpride(ROR = 4.07),paliperidone(ROR = 2.73),quetiapine(ROR = 1.83),clozapine(ROR = 1.61), olanzapine(ROR = 1.50), risperidone(ROR = 0.71). This study found that clozapine, olanzapine, amsulpride, quetiapine and paliperidone were correlated with constipation, while risperidone had the least effect on gastrointestinal function. Future analysis of the FAERS database in conjunction with other data sources will be essential for continuous monitoring of antipsychotics-related constipation."

Adverse events • Journal • CNS Disorders • Constipation • Gastroenterology • Gastrointestinal Disorder

The Safety and Clinical Effects of Amisulpride in Children and Adolescents with Psychiatric Disorders: A Case Series. (PubMed, J Child Adolesc Psychopharmacol) - "Observed side effects included increased appetite, weight gain, sedation, and mild extrapyramidal symptoms. Amisulpride may have promise for study and future use in children and adolescents with psychiatric disorders and severe symptoms."

Journal • Anesthesia • Autism Spectrum Disorder • CNS Disorders • Genetic Disorders • Mental Retardation • Mood Disorders • Obsessive-Compulsive Disorder • Psychiatry

PHARMACOLOGICAL OPTIONS FOR MANAGING BURNING MOUTH SYNDROME. (WRMC 2025) - "Other medications evaluated included: amisulpride, aripiprazole, bupivacaine, cannabis, duloxetine, gabapentin, lysozyme-lactoperoxidase, melatonin, milnacipran, naltrexone, olanzapine, palmitoylethanlamide, paroxetine, pramipexole, pregabalin, sertraline, tibolone, and vortioxetine...Conclusions Although few studies have evaluated the use of pharmacological agents in the management of BMS, several have demonstrated efficacy including ALA, clonazepam, and capsaicin. Providers may refer to this review when managing patients with BMS. Drug Mechanism of Actions and Adverse Effects"

Dyspepsia • Pain

Effect of antipsychotics on the focal adhesion pathway. (PubMed, World J Biol Psychiatry) - "NT2-N (neuron-like) cells were exposed to treatment with amisulpride, aripiprazole, chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, risperidone, or vehicle for 24 h. Our results support the hypothesis that focal adhesion pathways may play a role in the pathophysiology of bipolar disorder and schizophrenia. Moreover, the data underscore the importance of differentiating medication effects from disease mechanisms in psychiatric research, a challenge compounded by the medicated state of most study participants."

Journal • Bipolar Disorder • CNS Disorders • Mood Disorders • Psychiatry • Schizophrenia